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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP DHP 2.7/3.5 MED LE SHORT 1-HO L69 ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE

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SYNTHES GMBH VA-LCP DHP 2.7/3.5 MED LE SHORT 1-HO L69 ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE Back to Search Results
Catalog Number 04.117.501S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 1 of 4 for (b)(4). It was reported by the customer in (b)(6) that during an open reduction internal fixation surgery for humeral condyle fracture surgery on (b)(6) 2022, it was observed that an unknown locking screw device did not lock into the fixation plate device after drilling with a threaded guide device (03. 133. 008). According to the report, the surgeon removed the screw to check the direction and reinserted it but still did not lock. It was reported that the surgeon used drill guide device (03. 133. 007), and even though he changed direction and drilled, he could not lock it to the plate. It was reported that the event occurred in both the 2nd and 3rd holes from the distal end, so the surgeon tried other screw holes and they were able to lock without problems. Another fixation plate device was used to complete the procedure successfully with 30 minutes of delay. There were no adverse patient consequences nor surgical delay reported. The patient was reported to be in stable condition. No additional information was provided. This report is for one (1) va-lcp dhp 2. 7/3. 5 med le short 1-ho l69 device. This complaint involves four(4) devices.
 
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Brand NameVA-LCP DHP 2.7/3.5 MED LE SHORT 1-HO L69
Type of DeviceORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer (Section G)
WERK MEZZOVICO (CH)
via cavazz 5
mezzovico 6805
SZ 6805
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14137451
MDR Text Key290544276
Report Number8030965-2022-02500
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K120070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number04.117.501S
Device Lot Number259P135
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/22/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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